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Richard Wolf GmbH · Model 8654911 · UDI-DI 04055207018835

FJL
10
510(k) clearances
953
Adverse events (5 deaths)
33
Recalls
40
Facilities

Description

LASER WORKING INSERT 12/30 7.5FR round, working channel for instruments up to 7.5Fr, compatible with 24Fr sheaths, and telescopes Ø 4mm, with introduction port, bayonet-cap, reusable

Recalls

DateFirmReason
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.